UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041522 |
|---|---|
| Receipt number | R000046005 |
| Scientific Title | Relationships between genome DNAs in dental plaque and periodontal disease |
| Date of disclosure of the study information | 2020/08/24 |
| Last modified on | 2024/02/26 17:12:36 |
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Basic information
Public title
Relationships between genome DNAs in dental plaque and periodontal disease
Acronym
Relationships between genome DNAs in dental plaque and periodontal disease
Scientific Title
Relationships between genome DNAs in dental plaque and periodontal disease
Scientific Title:Acronym
Relationships between genome DNAs in dental plaque and periodontal disease
Region
| Japan |
Condition
Condition
periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Focus of periodontal disease is plaque in dental pockets. However, components of the plaque are analyzed only for major bacterias, but not for minor bacterias as well as bacterias with difficulty in culture. In addition, viruses and archaea have been hardly analyzed. In this study, the plaque is analyzed with next generation sequence; for most of all DNA sequence in the plaque, and a relationship with progress of periodontal disease is validated.
Basic objectives2
Others
Basic objectives -Others
To analyze changes in components of the plaque along with treatment for periodontal disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Components of the plaque, pocket depth, bleeding on probing, mobility
Key secondary outcomes
As the first examination, primary outcomes are evaluated and the plaque is kept. Six month after treatment, same examination and the keeping sample plaque are made.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients in which pocket depth is less thann 3 mm (control) and absorption of alveolar bone was observed (patients with periodontal disease) at preventative dental clinic in Okayama University Hospital, and patients with Down syndrome at Special Needs Dentistry in Okayama University Hospital from June 1st, 2020 to Sep 30th, 2021.
2) Patients who can show informed consent with document to participate this study with free will.
Key exclusion criteria
1) Woman with pregnant or with possibility of pregnant.
2) Patients with difficulty in continuous consultation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MAEDA |
| Middle name | |
| Last name | Shigeru |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
7000867
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862356721
maedas@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | MAEDA |
| Middle name | |
| Last name | Shigeru |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
7000867
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-6721
Homepage URL
maedas@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology, Okayama University Hospital, Okayama University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-aid for scientific research, Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Comittee, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862356938
mae6605@adm.okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
1) The proportions of the constituent bacterial flora in periodontal pockets were examined in 10 persons with Down syndrome and 6 persons without Down syndrome. The results showed that the mean component ratio of Actinomycetales was significantly higher in preventive dental patients than in patients with Down's syndrome.
2) Plaques were collected from six patients with Down syndrome after about six months of treatment. The results showed a predominant increase in Spirochaetales.
Results date posted
| 2024 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
depth of periodontal pocket, bleeding on probing, tooth mobility, DNA analysis of plaque
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046005
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